Patient safety

Clinical coding

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Highlights

Results from two colonoscopies may suggest proper interval for third

Information from two colonoscopies may identify low-risk populations that benefit little from intense surveillance, researchers concluded.

To determine the risk for clinically significant adenoma recurrence, researchers conducted a prospective cohort study of 564 patients at VA and other academic and private centers in North America. Participants came from the Aspirin/Folate Polyp Prevention Study, a randomized clinical trial comparing aspirin and folic acid to placebo. All participants had one or more adenomas (their first) found on complete colonoscopy at entry. All participants then underwent second and third study colonoscopies at three-year intervals.

Researchers looked for the proportion of patients with high-risk findings at the third colonoscopy, defined as either one or two adenomas >1 cm with tubulovillous or villous histologic features or high-grade dysplasia, or more than three adenomas overall.

Fifty-eight participants (10.3%) had high-risk findings at the third study examination. If the second examination showed high-risk findings, then results from the first one added no significant information about the probability of high-risk findings on the third (18.2% for high-risk findings on the first examination vs. 20% for low-risk findings; P=0.78). If the second examination showed no adenomas, then the results from the first examination added significant information about the probability of high-risk findings on the third examination (12.3% if the first examination had high-risk findings vs. 4.9% if the first examination had low-risk findings; P=0.015).

Relatively few participants (5%) with low-risk findings on their first two examinations had high-risk results on their third colonoscopy, leading researchers to write, "Our findings suggest that a longer follow-up interval may be appropriate for this latter and much larger group."

Depression risk in diabetics may be overstated, study suggests

The risk for depression in patients with newly diagnosed or existing diabetes may not be as high as previously suggested, a new report indicates.

Earlier studies have found a substantially increased risk for depression among patients with diabetes but have not controlled for number of outpatient visits or other contact with health care professionals. Researchers performed a prospective study in patients with incident (n=2,932) or prevalent (n=14,144) diabetes and nondiabetic controls. Patients and controls were matched based on age and sex alone or on age, sex and number of outpatient primary care visits. The authors then used logistic regression to compare new diagnoses of depression among patients with diabetes and controls without. The study results appear in the July/August Annals of Family Medicine.

In all groups, the likelihood of a depression diagnosis decreased as primary care visits increased. When patients and controls were matched for age and sex alone, a statistically significant association was noted between diabetes and depression risk in patients with prevalent diabetes and few primary care visits compared with controls (odds ratio [OR], 1.46; 95% CI, 0.77-1.17). This relationship was less strong, however, when patients had over 10 primary care visits (OR, 0.95; 95% CI, 0.77-1.17). When patients with prevalent diabetes were matched with controls for age, sex, and number of primary care visits, a depression diagnosis was less likely in diabetics who made at least four primary care visits compared with controls (OR, 0.99; 95% CI, 0.80-1.23) and more likely in diabetics who did not (OR, 1.32; 95% CI, 1.07-1.63). Findings were similar in patients with incident diabetes.

The authors noted that diagnoses of depression were based on the medical record rather than independent evaluations and that their results may not apply to other settings. However, they concluded that patients with diabetes seem no more likely to develop depression than patients who have other chronic diseases and frequently make outpatient visits. Future studies, they wrote, should examine why few outpatient visits seem to be associated with a higher depression risk.

Test yourself

MKSAP quiz: isolated hematuria

A 36-year-old woman is evaluated during a routine physical examination. Four years ago, she was diagnosed with acute renal failure secondary to systemic lupus erythematosus. Renal biopsy revealed diffuse proliferative glomerulonephritis. She was treated with prednisone and cyclophosphamide for two years. Two years ago, this therapy was discontinued. Since that time, she has felt well, and her proteinuria and hematuria have resolved. Physical examination today is unremarkable.

Laboratory studies

Hemoglobin

11.6 g/dL (116 g/L)

Erythrocyte sedimentation rate

37 mm/h

Anti–doubled-stranded DNA antibodies

Negative

Serum complement (C3 and C4)

Normal

Urinalysis

No protein; 3+ hematuria; no erythrocyte casts

Two weeks later, repeat urinalysis again reveals isolated hematuria.

Which of the following is the most appropriate next step in this patient's management?

HIV therapy

Susceptibility testing associated with patient survival

Patients who had HIV-1 genotype or phenotype (GPT) susceptibility testing were less likely to die than were patients who did not have testing, a study found.

To evaluate the association between GPT and survival, researchers conducted a cohort study of 2,699 HIV-infected patients eligible for plasma HIV RNA level >1,000 copies/mL at 10 U.S. HIV clinics from 1999 through 2005. They reported results in Annals of Internal Medicine.

Patients were followed for a median of 3.3 years, during which 915 (34%) underwent GPT. The first GPT test was used for analysis. Patients who'd had GPT had lower mortality rates than those who did not (2.0 vs. 2.7 deaths per 100 person years). GPT was associated with improved survival (adjusted hazard ratio for death [HR], 0.69; 95% confidence interval [CI], 0.51-0.94; P=0.017) after controlling for demographic characteristics, CD4+ cell count, HIV RNA level and intensity of clinical follow-up.

Authors acknowledged that the observational study did not randomize who received GPT, so it cannot distinguish whether the association was due to better antiretroviral treatment selection in tested patients or due to confounding. However, they concluded that GPT was independently associated with improved survival among HAART-experienced patients.

HAART associated with less resistance when started at higher CD4 cell counts

Highly active antiretroviral therapy (HAART) is associated with less resistance at treatment failure when started at higher CD4 cell counts, according to a new study.

Researchers examined data from 683 HIV-infected patients participating in the HIV Outpatient Study who began HAART in 1999 or later. The authors determined the frequency of resistance mutations when HAART failed according to the CD4 cell count at which HAART was initiated. The study results appear in the August Journal of Acquired Immune Deficiency Syndromes.

Two hundred forty-three patients had virologic failure and of these, 78 were tested for genotype resistance. Of the latter group, 50% of those who began HAART at a CD4 cell count of 0-99 cells/mm3 or 200-349 cells/mm3 had HIV resistance mutations compared with 22% of those who started HAART at 350 cells/mm3 or greater (P=0.062). Nucleoside reverse transcriptase inhibitor-associated mutations were noted in 48%, 31% and 11% of those who began therapy at 0-199 cells/mm3, 200-349 cells/mm3 and at least 349 cells/mm3, respectively (P=0.005). Similar trends were noted for nonnucleoside reverse transcriptor inhibitor-associated mutations and protease inhibitor-associated mutations (P=0.040 and 0.063, respectively). In addition, median time to treatment failure was longer for patients who began HAART at higher CD4 cell counts (20.8 months for a CD4 cell count >350 cells/mm3, 10.5 months for a CD4 cell count of 200-349 cells/mm3, and 7.7 months for a CD4 cell count of 0-199 cells/mm3; P=0.026).

The authors noted that their study did not involve a large number of patients and called their findings preliminary. However, they concluded that resistance mutations were more common in patients who began HAART at CD4 cell counts of less than 350 cells/mm3. "Initiating HAART at higher CD4 cell counts may decrease the risk of developing treatment-limiting antiretroviral resistance," they wrote.

FDA update

Recalls on ventilators, acetaminophen drops, sodium injections

The following items have been recalled in the last week, according to the FDA:

The BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P, due to power supply failures on some ventilators. The product was distributed from August 2006 through April 11, 2008. Customers may contact Respironics U.S. Customer Service at 877-387-3377. This is a class I recall.

Medtronic’s Quick-set infusion sets used with MiniMed Paradigm insulin pumps because the sets may not allow the insulin pump to vent air pressure properly. This could result in the device delivering too much or too little insulin and may lead to serious injury or death. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8"; patients should discontinue using “Lot 8” sets. This is a voluntary recall by the manufacturer, which will replace the sets for free.

All lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16-ounce (473 ml) bulk containers, manufactured by Pharmaceutical Associates, Inc. Because the 16-ounce container is comparable in size to the packaging of regular-strength acetaminophen liquid preparations, dosing errors may occur. This is a voluntary recall by the manufacturer.

Lot #370-9004 of Mallinckrodt Sodium Chromate Cr-51 Injection, because routine post-market testing found the product to be subpotent. This is a voluntary recall by the manufacturer.

Blood thinner prasugrel (Effient) to reduce the risk of blood clots in angioplasty patients. The drug’s labeling will include a boxed warning that prasugrel can cause significant, sometimes fatal, bleeding. It shouldn’t be used in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

Fentanyl buccal soluble film (Onsolis) to help cancer patients manage breakthrough pain. The absorbable film, which sticks to the inside of the cheek, is meant for opioid-tolerant patients age 18 years and older who already use opioid pain management continuously. The drug was approved with a boxed warning against use to manage migraines, dental pain, or postoperative pain, or use by patients who take opioids intermittently or on an as-needed basis. The drug will only be available through a restricted distribution program, meaning only prescribers, patients and pharmacies registered with the program, called FOCUS, will be able to prescribe, dispense, and receive the drug.

A one-dose formulation of emergency contraception pill levonorgestrel (Plan B One-Step). The original pill requires two doses. People age 17 years and older will be able to buy Plan B One-Step over the counter; those 16 years of age and under will need a prescription.

Health care providers need to carefully monitor patients who take these drugs for infection, the FDA said, and should consider adjusting immunosuppression therapy for any who develop BK virus-associated nephropathy.

Patient safety

HRSA invites providers to join patient safety collaborative

The Health Resources and Services Administration (HRSA) is inviting community-based teams of health care providers to join the Patient Safety and Clinical Pharmacy Services Collaborative (PSPC). The PSPC is an ongoing, and growing, action learning program focused on integrating clinical pharmacy services to significantly improve health outcomes and to improve patient safety. The group uses a fast-paced, iterative improvement method to support teams of health care providers in testing and spreading leading practices.

HRSA is enrolling teams now. They are seeking highly committed community teams made up of members from multiple organizations that serve a defined patient population of focus. Teams should include at least one HRSA-supported organization and ideally would include additional partners who together serve that defined patient population. The participation package can also be found on the HRSA Knowledge Gateway.

Clinical coding

Free coding seminars offered to prepare for ICD-10

The ICD-10 coding system won’t be implemented until 2013, but providers can begin preparing now to make sure their practices have a smooth transition. Successfully implementing the ICD-10 clinical coding system will be an important step in improving the quality of health data and patient care. To help educate users, the American Academy of Professional Coders is offering free ICD-10 implementation training Webinars to review the necessary steps for a successful implementation. The three-part series of Webinars for providers will discuss an overview of the ICD-10 rule and the impact of ICD-10 on provider organizations and will dive into the first steps of implementation. A separate Webinar for payers is also being offered.

The series of Webinars kicked off this past Thursday, July 16, but archived information—including past Webinar videos, audio versions, presentation materials, and questions and answers—will be provided to all registrants. More information and registration are available online.

Cartoon caption contest

Put words in our mouth

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.

E-mail all entries by July 23. ACP staff will choose three finalists and post them in the July 28 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the Aug. 4 edition.

The most appropriate next step in this patient's management is referral for cystoscopy. Hemorrhagic cystitis and bladder cancer are uncommon side effects associated with cyclophosphamide therapy and may develop during treatment and years after exposure to this agent. Cystoscopy would exclude a diagnosis of an underlying malignancy to account for this patient's hematuria.

This patient's symptoms are not characteristic of a lupus flare. In addition, her urine sediment shows no cellular casts, which would suggest active glomerular disease. Therefore, reinitiation of prednisone and cyclophosphamide therapy or renal biopsy is not indicated. Urine culture would not be useful because there is no evidence of pyuria or bacteriuria.

Key Points

Hemorrhagic cystitis and bladder cancer are uncommon side effects of cyclophosphamide therapy.

Follow-up cystoscopy is indicated for patients with hematuria and a history of treatment with cyclophosphamide.

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Copyright 2009 by the American College of Physicians.

Test yourself

A 54-year-old woman is evaluated for shortness of breath of 3 months' duration and a 4.5-kg (10-lb) weight loss over the preceding 2 months. She has a 35-pack-year smoking history. Following a physical exam and further testing, what is the most appropriate treatment?

Internal Medicine Meeting 2015 Live Simulcast!

Unable to attend the meeting this year? On Saturday, May 2, seven sessions will be streamed live from the meeting. Register for the simulcast and earn CME credit after watching each session. Watch it live or download for later viewing.

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